Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

Netherlands Cancer Institute (NKI)

Status and phase

Completed

Early Phase 1

Conditions

Cocaine Addiction

Treatments

Drug: Dexamphetamine

Study type

Interventional

Funder types

Other

Identifiers

NCT02768441

DAM001DFM

Details and patient eligibility

About

The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.

Enrollment

12 patients

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have completed at least 80% of the previous study (CATCH)
Be able and willing to participate in the study and assessments
Have provided written informed consent.

Exclusion criteria

Any intake of dexamphetamine 7 days or less before the start of the proposed study;
Contraindications for dexamphetamine
(desired) pregnancy or continued lactation
Insufficient command of the Dutch language
Current participation in another trial